Senior Mechanical Engineer

Our client is an innovative deep-tech startup developing next-generation biosensor systems for in-vitro diagnostics. Combining photonics, microfluidics, and electronics , they are transforming complex lab processes into compact, high-performance diagnostic devices . Their mission is to accelerate access to accurate, fast, and energy-efficient diagnostics through advanced engineering and scalable product development.

Mission

Lead the productization and manufacturing scale-up of biosensor systems, ensuring a smooth transition from R&D to commercial production . The Senior Mechanical Engineer will own the full mechanical design process—from early prototyping to regulatory-compliant, cost-effective mass production —bridging innovation and manufacturability in a multidisciplinary environment.

Responsibilities

Productization & Manufacturing Scale-up

• Own the mechanical design process from prototyping to production.
• Optimize mechanical housings and microfluidic components for CNC machining, injection molding , and other scalable methods.
• Develop and implement scalable manufacturing strategies with contract manufacturers.
• Drive cost-reduction initiatives without compromising performance or quality.

Design, Validation & Compliance

• Create and refine mechanical assemblies using Solid Works, CATIA, or Fusion 360 .
• Apply tolerance analysis, GD&T , and DFM/DFA principles to ensure robust manufacturability.
• Perform FEA/CFD simulations to validate performance (fluidics, thermal, structural).
• Lead risk assessments (FMEA) and failure analysis for system reliability.

Cross-functional Collaboration

• Work closely with photonics, microfluidics, and electronics teams to ensure seamless integration and transfer to production.
• Support regulatory documentation (ISO 13485, MDR/FDA) for compliance and medical device approval.
• Define quality control protocols and assembly procedures to ensure production readiness.

Requirements

• Bachelor’s or Master’s degree in Mechanical, Industrial Engineering , or related fields.
• 4+ years of experience in mechanical design & product development , ideally in medical devices , diagnostics, or precision engineering.
• Proven track record transitioning lab prototypes to commercial products .
• Strong knowledge of manufacturing processes : CNC machining, injection molding, sheet metal, etc.
• Advanced proficiency in CAD tools :
  Solid Works, CATIA, or Fusion 360.
• Solid understanding of fluid handling, sealing techniques , and microfluidic integration.
• Experience in tolerancing (GD&T) and design-for-manufacturability (DFM) .
• Familiarity with ISO 13485, FDA, MDR regulations and validation processes.
• Fluent in English (spoken and written), with ability to produce technical documentation and collaborate across disciplines.